FDA launches AI-driven pilot to review trial data in real time, aiming to speed clinical studies

Washington officials said the Food and Drug Administration is starting a new program to speed clinical trials by reviewing data as it is generated.

The first pilots will use real-time data from trials run by AstraZeneca and Amgen. AstraZeneca is testing a combination therapy for an aggressive lymphoma in a Phase 2 study at MD Anderson and the University of Pennsylvania.

Amgen is evaluating a treatment for small-cell lung cancer in a Phase 1b trial.

The FDA is asking the public to comment on a broader pilot that would let companies apply artificial-intelligence tools to safety monitoring, dose selection, signal detection and patient recruitment, with the goal of shortening development timelines.